BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4100341 · Received September 18, 2014

    Report

    Report Number
    1061932-2014-02362
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE QUICK DISCONNECT (QD4) WAS DISCONNECTED. THE FSE RECONNECTED QD4 TO RESOLVE THE ISSUE. THE FSE PERFORMED VERIFICATION OF INSTRUMENT TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED BLOOD, DILUENT AND CLENZ LEAK OF APPROXIMATELY TWENTY (20) ML FROM THE BOTTOM LEFT SIDE OF THE COULTER LH 780 HEMATOLOGY ANALYZER WHILE RUNNING STARTUP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND LABORATORY COAT WHEN THE LEAK OCCURRED. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579774 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1